Kornimate/medical-research-clean huggingface dataset:
evaluation the intracranial volume pressure response in increased intracranial pressure

Conditions: Brain Injury; Intracranial Hypertension

Summary: the purpose of this study is to discover a mathematic equation to express the intracranial pressure-volume (p-v) curve and a single indicator to reflect the status of the curve.

monitoring of intracranial pressure (icp) has been used in the management of patients with increased icp, or in whom increased icp was suspected. icp depends on the relative constancy of total volume inside the skull, comprising cerebrospinal fluid (csf), blood, and brain tissue. the changes of csf volume affect the ventricular fluid pressure and defined it as volume pressure response (vpr). the shape or curve of the intracranial volume-pressure (v-p) relationship is well known in daily neurosurgical practice. if the p-v curve can be expressed by mathematic manner, then there should be an indicator to reflect the status of the curve. this study is conducted in order to understand the difference of each p-v curve in patients with increased intracranial pressure. the individual vpr values have been tested with three mathematical models (linear, parabolic and exponential regression equation).

Eligibility criteria:
inclusion criteria: * patients with severe brain damage * underwent bilateral external ventricular drainage (evd) exclusion criteria: -

Keywords: pressure-volume curve intracranial pressure volume pressure response pressure-volume relationship mathematical model
phase ii study of calcitonin for tumoral calcinosis

Conditions: Calcinosis

Summary: objectives: i. determine whether intermittent, long-term, subcutaneous administration of calcitonin increases phosphaturia, reduces hyperphosphatemia, and increases intact parathyroid hormone levels in patients with tumoral calcinosis. ii. determine whether calcitonin reduces or prevents tumor recurrence. iii. determine whether hyperphosphatemia abolishes the normal circadian pattern of serum phosphorus. iv. determine how repetitive calcitonin administration alters the biochemical markers of bone metabolism in osteopenic patients with tumoral calcinosis.

protocol outline: patients are treated with subcutaneous injections of salmon calcitonin every 3 weeks. ondansetron premedication and intravenous hydration are also administered. patients are followed for disease progression and tumor recurrence.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- histologically confirmed tumoral calcinosis --prior/concurrent therapy-- prior surgical resection of calcinotic lesion required

Keywords: arthritis & connective tissue diseases rare disease tumoral calcinosis
study of an early change of a chemotherapeutic doublet versus four cycles of chemotherapy in advanced non small cell lung cancer

Conditions: Non Small Cell Lung Carcinoma

Summary: the optimal strategy in advanced non small cell lung cancer with stable disease is not well known. there is no published study assessing an early change of chemotherapeutic drugs in these patients.accordingly, we conduct this trial with the objective to improve the rate of objective responses by the switch to another doublet after 2 cycles of cddp-gemcitabine association for patients with stable diseases (sd).

patients with stage iv nsclc and measurable disease are included in a randomized phase ii trial comparing for patients with stable disease after 2 cycles of a platin (p)-gemcitabine doublet (p d1: 75 mg/m2, gemcitabine 1 250 mg/m2 d1, d8 every three weeks) two subsequent cycles of this doublet (arm a) to a switch to another doublet (arm b) : paclitaxel 100 mg/m2 d1, d8, d15, gemcitabine 1 250 mg/m2 d1, d8, every four weeks.platin, gemcitabine and paclitaxel are administered according nadir and pre-cycle haematologic evaluations (with dose decrease if needed). response criteria are assessed with recist classification by the investigator panel.

Eligibility criteria:
inclusion criteria: * histologically or cytologically proved stage iv or pleural stage iii nsclc (neoplastic pleurisy confirmed). * metastatic relapses allowed in not irradiated area. * age between 18 and 70 years * chemonaïve patients * at least one measurable target lesion according to recist criteria in non previously irradiated area. * performance status \< 2 * normal hepatic and renal function, absolute neutrophil count \>1,5 giga/l, platelets \>100 giga/l. * written informed consent. * life expectancy \> 12 weeks. exclusion criteria: * sclc, bronchial-alveolar and neuro-endocrine carcinoma. * previous chemotherapeutic treatment. * symptomatic brain metastases. * superior vena cava syndrome. * other concomitant diseases: heart failure, angina pectoris, arrhythmia , recent myocardial infarction. * peripheral neuropathy grade ≥2. * past or concomitance of another cancer except baso-cellular carcinoma of the skin or in situ cervical carcinoma. * hypersensitivity to paclitaxel or polysorbate 80. * pregnancy or breast feeding. * any concomitant radiotherapy, except palliative bone irradiation. * follow-up of the patient impossible. * prisoners.

Keywords: non small cell lung carcinoma cisplatin gemcitabine paclitaxel
a prospective study to determine the effectiveness of reaming in reducing fat emboli to the lungs

Conditions: Diaphyseal Femur Fracture

Summary: the purpose of the study is to see if there is a difference in the amount of fat droplets reaching the heart during surgery between the standard reamer currently used and a new reamer system which is expected to reduce the fat going into the blood, via an intraoperative echocardiography done through the food pipe.

reamed intramedullary nailing of diaphyseal femur fractures remains the standard of care for treatment of these fractures. pressurization of the femoral canal during reaming leads to extra vasations of fat emboli into the systemic circulation, resulting in deposition of fat droplets in the pulmonary vasculature. this phenomenon has been well documented by use of transesophageal echocardiography. a novel reaming system has recently become available that may limit this phenomenon. the new reamer system incorporates irrigation and aspiration during reaming, theoretically minimizing pressurization and fat emboli. additionally, this reamer system allows for one pass reaming as compared to the current system which requires multiple reaming passes. the objective of this study is to determine effectiveness of reaming in diminishing fat emboli to the lungs as evidenced by decreased numbers of large fat droplets entering the right heart as measured by transesophageal echocardiography during the reaming process. this will determine if there is a benefit to aspiration during reaming as would be expected. during the reaming process a transesophageal echo cardiogram will be performed to analyze the presence or absence of emboli and the mean regarding the total time that each of the embolic grades is present during each of the intervals across the patient groups

Eligibility criteria:
inclusion criteria: * diaphyseal femur fractures undergoing reamed intramedullary nailing * male or female * 18 years of age or older exclusion criteria: * none

Keywords: reaming fracture emboli
drug interactions between echinacea purpurea and etravirine

Conditions: HIV

Summary: the purpose of this clinical trial is to characterize drug interactions between one medicinal herb: echinacea purpurea and the protease inhibitor etravirine.

because of its cyp3a4 inducer activity in the liver but its inhibitor effect at the intestinal site, concomitant administration of equinacea purpurea (a medicinal herb frequently used by hiv-infected patients) and etravirine (an hiv reverse transcriptase inhibitor) might result in clinically relevant pharmacokinetic drug interactions. 15 hiv-infected patients on stable antiretroviral therapy including etravirine at the dosage of 200 mg twice daily during at least 4 weeks will be enrolled. after their inclusion in the study, patients will receive echinacea purpurea root (500 mg every 8 hours) in addition to their antiretroviral treatment, from day 1 until two weeks later (day 14). on days 0 and 14, blood samples will be drawn immediately before and 1, 2, 4, 6, 8, 10 and 12 hours after the administration of an etravirine dose, and etravirine concentrations in plasma will be determined by high performance liquid chromatography using a validated method.

Eligibility criteria:
inclusion criteria: 1. patients infected with hiv-1 (at least one documented positive western-blot). 2. age 18 years or more. 3. patients receiving antiretroviral therapy including etravirine at the approved dose of 200 mg twice daily for at least 4 weeks 4. hiv viral load in plasma \<50 copies / ml 5. absence of acute infections and / or tumors in the three months prior to inclusion. 6. subject able to follow the treatment period, without suspicion of poor adherence in previous antiretroviral treatments. 7. voluntary written informed consent. exclusion criteria: 1. any clinical or historical observation that could interfere with the pharmacokinetics of medications, such as gastrointestinal illness or surgery (except for herniotomy and appendectomy), changes in the composition of plasma proteins, some indication of hepatic or renal dysfunction. 2. antiretroviral regimen including drugs ritonavir or atazanavir (cyp3a4 inhibitors) 3. concomitant treatment with drugs inductors of cyp3a4 (rifampicin, fenitoin, carbamazepin, ...) 4. active alcohol consumption (\> 50 g / day) or illicit drugs (except cannabis). 5. pregnancy or lactation

Keywords: etravirine echinacea purpurea interaction
effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis (ricch-ivt)

Conditions: Remote Ischemic Conditioning

Summary: the purpose of this study is to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis

in this study, cases of ischemic stroke who undergo intravenous thrombolysis within 4.5 hours from onset are included. the ric group receive basic treatment and remote ischemic conditioning for 200mmhg at 6 and 18-24 hours after intravenous thrombolysis. the sham-ric group receive basic treatment and remote ischemic conditioning for 60mmhg at 6 and 18-24 hours after intravenous thrombolysis. both groups underwent cerebral hemodynamics after ric and recorded the relevant indexes. the investigators aimed to determine the effect of remote ischemic conditioning on cerebral hemodynamics in patients after intravenous thrombolysis.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and \< 80 years, both sexes; 2. a clear clinical diagnosis of acute ischemic stroke and treatment with standard rt-pa (0.9 mg/kg) ivt within 4.5 h of stroke onset; 3. pre-onset modified rankin scale (mrs) score ≤1; 4. baseline national institute of health stroke scale (nihss) score ≥5 and ≤25; 5. glasgow coma scale score ≥8. exclusion criteria: 1. having received bridging therapy (ivt plus mechanical thrombectomy); 2. previous history of atrial fibrillation or electrocardiographic evidence of atrial fibrillation; 3. contraindications to ric treatment or previous ric treatment or similar treatment; 4. pregnancy or breastfeeding; 5. life expectancy of ≤3 months or inability to complete the study for other reasons; 6. unwillingness to be followed up or poor treatment compliance or participation in other clinical studies; 7. had insufficient bilateral temporal bone windows for insonation of the middle cerebral artery.

Keywords: remote ischemic conditioning intravenous thrombolysis cerebral hemodynamics cerebral autoregulation cerebral blood flow velocity
patient-reported outcomes of postsurgical pain and health related quality of life

Conditions: Post Surgical Pain

Summary: this study will investigate the impact of post-surgical pain (psp) on health related quality of life (hrqol) within the first six months following surgery using patient-reported outcome (pro) measures, and to investigate medical recovery measures such as ambulation and oral feeding time as secondary outcomes.

pain and recovery after surgery are extremely concerned by patients undergoing surgery. though it is important to understand the recovery course of postsurgical pain and recovery, most previous studies just focused on one specific time point, and the results were inconsistent. to investigate the impact of psp on hrqol within the first six months following surgery using pro measures, patients undergoing several specific surgeries will be interviewed. patients' medical charts will be reviewed by investigators to record sociodemographic and clinical data.

Eligibility criteria:
inclusion criteria: * 18 years or older * undergoing general or regional anesthesia * hospitalized for at least 24 hours after surgery exclusion criteria: * existing diagnoses of psychiatric pathology * surgery cancellation * unable to give informed consent * unable to read and write

Keywords: post-surgical pain health-related quality of life
the effect of applying modified nutric scoring system to evaluate the nutrition risk and giving different types of nutritional support on clinical outcomes in critically ill patients

Conditions: Critical Illness

Summary: malnutrition is very common in critically ill patients. it is quite important to evaluate nutritional status precisely. heyland et al firstly reported nutric score including age, apache ii score, sofa score, number of commorbidities, days from hospital to icu admission and il-6. because the il-6 is not routinely checked at icu. a modified nutric score without il-6 is more practical. previous studies showed lower in-hospital mortality in higher nutritional risk patients with higher caloric intake compared with lower caloric intake. however, there is still controversial regarding the in-hospital mortality between full caloric feeding and permissive underfeeding in critically ill patients. herein the investigators conduct a study to investigate what kinds of nutritional supplements will decrease in-hospital mortality in different nutritional risk patients.


Eligibility criteria:
inclusion criteria: * 1. medical intensive care unit patients 2. age elder than 20 years old 3. intubated with ventilator support patients 4. predicted icu stay longer than 72 hours exclusion criteria: * 1. npo patients 2. contraindication for enteral feeding 3. tpn use 4. upper or lower gi bleeding patients 5. feeding with gastrostomy or jejunostomy patients 6. metoclopramide related eps or torsades de pointes history
retinal vein occlusion and obstructive sleep apnea: a case control study

Conditions: Retinal Vein Occlusion; Obstructive Sleep Apnea

Summary: this study purpose is to evaluate the association between retinal vein occlusion and obstructive sleep apnea.

there will be two groups of 50 patients. one with retinal vein occlusion, and the other one, with no retinal vein occlusion will be chosen from the consultation. the compared group will be paired on different criteria including hypertension, ocular hypertension, diabetes, sex, age. they will all spend a night at home with a sleeping monitor (nox t3) in order to evaluate if they have an obstructive sleep apnea.

Eligibility criteria:
inclusion criteria: * all patients with an retinal vein occlusion for one group (patients) * all patients with no retinal vein occlusion for the other group (control) non-inclusion criteria: * minor * severe insomnia * neuromuscular disease with respiratory muscle impairment * chronic opioid medication * pregnancy women. * patient under guardianship

Keywords: retinal vein occlusion central retinal vein occlusion branch retinal vein occlusion obstructive sleep apnea sleep apnea
prevention of venous thromboembolic events after elective orthopaedic surgery in patients treated with pradaxa

Conditions: Venous Thromboembolism

Summary: observational cohort study on the prevention of venous thromboembolic events after elective orthopaedic surgery for total knee replacement or total hip replacement iin patients treated with pradaxa to evaluate the efficacy ant safety of pradaxa in real-life conditions


Eligibility criteria:
inclusion criteria: 1. patients treated with pradaxa undergoing surgery for total knee replacement or total hip replacement 2. patients 18 years of age or older at the time of recruitment exclusion criteria: 1. patients presenting contraindication to prescription of pradaxa 2. patients in whom long term anti vitamin k treatment is indicated
zanubrutinib and rituximab followed by r-dhaox then maintenance with zanubrutinib for newly-diagnosed mcl

Conditions: Mantle Cell Lymphoma; Newly-diagnosed Mantle Cell Lymphoma

Summary: this phase 2 trial studies the efficacy and safety of zanubrutinib plus rituximab followed by r-dhaox (rituximab, dexamethasone, cytarabine and oxaliplatin) regimen then maintenance with zanubrutinib for newly-diagnosed mantle cell lymphoma (mcl).


Eligibility criteria:
inclusion criteria: * histologically confirmed cd20 positive mantle cell lymphoma; * patients with mcl-related symptomatic and need immediate therapy; include any of the following: (1) blastoid variant (2) pleomorphic variant (3) ki-67 ≥30% (4) bulky mass \> 7 cm or ≥2 tumors, each ≥5 cm in diameter (5) mutations in tp53, c-myc or notch genes (6) size of spleen ≥20 cm (7) lymphoma b symptoms (8) mantle cell international prognostic score (mipi) \> 3 (9) lymphoma threatening organ function (10) elevated lactate dehydrogenase (11) peripheral blood white blood cell \> 50×10\^9/l (12) pancytopenia due to bone marrow involvement (13) pain due to lymphoma; * patients received no prior anti-lymphoma treatment; * at least one evaluable lesion according to 2014 lugano criteria; * ann arbor stage ii-iv; * eastern cooperative oncology group (ecog) of 0-2; * life expectancy \> 3 months; * able to participate in all required study procedures; * proper functioning of the major organs: 1) the absolute value of neutrophils (\>1.5×10\^9/l); 2) platelet count (\> 75×10\^9/l); 3) hemoglobin (\> 80 g/l); 4) serum creatinine \<1.5 times upper limit normal (uln) ; 5) serum total bilirubin \< 1.5 times uln; 6) aspartate aminotransferase (ast), alanine aminotransferase (alt) \< 2.5 times uln; 7) coagulation function: international normalized ratio (inr), prothrombin time (pt), activated partial thromboplastin time (aptt) \< 1.5 times uln (unless the subject is receiving anticoagulant therapy and pt and aptt are within the expected range at screening time); exclusion criteria: * involvement of central nervous system (cns) * patients with hemophagocytic syndrome; * patients with active bleeding, bleeding tendency or require anticoagulation treatment; * patients require treatment with strong cyp3a inhibitors; * uncontrolled active infection, with the exception of tumor-related b symptom fever; * history of human immunodeficiency virus (hiv) infection and/or patients with acquired immunodeficiency syndrome are known; * patients with active hepatitis b or active hepatitis c. patients who are positive for hepatitis b surface antigen (hbsag) or hepatitis c virus (hcv) antibodies at screening stage must pass further detection of hepatitis b virus (hbv) dna (no more than 1000 iu/ml) and hcv rna (no more than the lower limit of the detection method) in the row. hepatitis b carriers, stable hepatitis b (dna titer should not be higher than 1000 iu/ml) after drug treatment, and cured hepatitis c patients can be enrolled in the group; * diagnosed with or receiving treatment for malignancy other than lymphoma; * pregnant or breastfeeding women; * other researchers consider it unsuitable for patients to participate in this study.
a study of cin-107 in adults with treatment-resistant hypertension (rhtn)

Conditions: Resistant Hypertension

Summary: this is a randomized, double-blind, placebo-controlled, dose-ranging phase 2 study to evaluate the efficacy and safety of cin-107 as compared to placebo after 12 weeks of treatment in patients with treatment-resistant hypertension (rhtn).


Eligibility criteria:
inclusion criteria: * is on a stable regimen of ≥ 3 antihypertensive agents (one of which is a diuretic) for at least 4 weeks prior to randomization; * be at least 70% compliant to their anti-hypertensive medication regimen; * has a seated bp ≥ 130/80 mmhg; * agrees to comply with the contraception and reproduction restrictions of the study; and * able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines. exclusion criteria: * has a seated sbp ≥ 180 mmhg or dbp ≥ 110 mmhg; * has a body mass index (bmi) \> 40 kg/m2; * has an upper arm circumference \ 17 inches; * has been on night shifts at any time during the 4 weeks before screening; * is using a beta blocker for any primary indication other than systemic hypertension (eg, migraine headache); * is not willing or not able to discontinue an mra or a potassium sparing diuretic as part of an existing antihypertensive regimen; * is not willing or not able to discontinue taking a potassium supplement; * has documented estimated glomerular filtration rate (egfr) \< 45 ml/min/1.73m2 * has known and documented new york heart association stage iii or iv chronic heart failure * has had a stroke, transient ischemic attack, hypertensive encephalopathy, acute coronary syndrome, or hospitalization for heart failure within 6 months before screening; * has known current severe left ventricular outflow obstruction, such as obstructive hypertrophic cardiomyopathy and/or severe aortic valvular disease diagnosed from a prior echocardiogram; * major cardiac surgery (eg, cabg, valve replacement), peripheral arterial bypass surgery, or pci within 6 months before screening; * has chronic permanent atrial fibrillation; * has uncontrolled diabetes with glycosylated hemoglobin \> 9.5% at screening; * has planned dialysis or kidney transplant during the course of this study; * potassium \< 3.5 meq/l; * potassium \> 5.0 meq/l; * is positive for hiv antibody, hepatitis c virus rna, or hepatitis b surface antigen; * has typical consumption of ≥14 alcoholic drinks weekly.